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Thursday, May 10th 2007

OxyContin Sentlement Includes Criminal Liability

Well, This Is One Way Around That Pesky “Slow Release”

OxyContin has become the rural or poor man’s heroine. It is a problem as a drug of abuse without a doubt. Its abuse by snorting may be linked to lymphomas and lung problems.

And now, its manufacturer and executives are paying the price for such. The federal pleas and settlement stem from fraudulent marketing of OxyContin,

OxyContin is a powerful, long-acting narcotic that provides relief of serious pain for up to 12 hours. Initially, Purdue Pharma contended that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than do traditional, shorter-acting painkillers like Percocet or Vicodin.

That claim became the linchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller. Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion. Purdue Pharma heavily promoted OxyContin to doctors like general practitioners, who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients.

To resolve criminal and civil charges related to the drug’s “misbranding,” the parent of Purdue Pharma, the company that markets OxyContin, agreed to pay some $600 million in fines and other payments, one of the largest amounts ever paid by a drug company in such a case.

As the Times article summarizes it the basic claim is that while the FDA approved the Purdue claim that the time released formula might decrease the addictive potential of OxyContin compared to other opiate analgesics, Purdue went out and played up that as a fact. And in some cases just blatantly lied about the evidence for such a claim.

Now I don’t know enough about the Purdue Pharmaceuticals scandal to level my own judgment on their guilt or not. So my problem isn’t with the fine and federal monitoring of their business practices which they acquiesced too. Indeed, maybe the penalties should’ve been even greater.

The real debate this brings up is just how far do we want to go in criminalizing business practices?

[I]n a rare move, three executives of Purdue Pharma, including its president and its top lawyer, pleaded guilty today as individuals to misbranding, a criminal violation.

The three top former and current Purdue Pharma executives pleaded guilty to criminal misdemeanor charges of misbranding, a charge that does not require prosecutors to show knowledge or intent on the executives’ part.

Look, it isn’t like there is a real clear cut case here. I mean the basic theory of the case is that Purdue sales reps misrepresented a theory as a fact. There doesn’t appear to be evidence during this time that Purdue knew the abuse potential of OxyContin and was hiding it.

As well, the increased abuse of OxyContin requires obvious and warned against alteration of the drug. Like all oxycodone opiate analgesics, OxyContin can be abused merely by overingestion. But the abuse potential for OxyContin in this way isn’t largely greater than say Percocet. Why it became a near pandemic is because people were smashing it up and then ingesting, snorting or shooting it.

Since OxyContin is intended for long relief, it has a comparative large amount of oxycodone in it which, when the pill is intact, is released slowly into the body. If you smash it up and take it all at once…walla, you get a rush.

I mean how much responsibility do you want to put on those who merely enable drug users? Where is the personal responsibility? Of course beyond that, my feelings on the criminalization of street drugs including opiates is well fleshed out. But as long as these drugs are illegal or controlled, as in the case with prescription opiates, how much do we want to require of the manufacturers in making sure people don’t misuse their drugs? Is that really their responsibility?

Yes, the sales people were apparently playing up its lack of abuse or dependence when used as directed. Which apparently isn’t true. But clearly they warned against misuse. And that is where the biggest problem is in terms of the abuse of this drug. But I guess the government thinks their sales reps and warnings and marketing just didn’t do enough?

And that rises to criminal liability?

This was far from an open and shut case. Clearly the fact Purdue plead it out says something. But there are factors which motivate such – say, defense costs and intangibles like the reputation and sales hit of a trial – beyond the conclusion that you’re actually guilty of what you’re charged with or that you’re going to definitely lose the case before you.

NY Times’ Podcast

Indeed, individual civil suits against Purdue in state courts don’t exactly have the best track record. Especially when the medication has been abused by the Plaintiffs in a manner beyond the scope of its intended use. So the idea that a criminal case was inbounds and appropriate didn’t exactly look reasonable when the the U.S. Attorney started looking into this whole mess.

Perhaps the most shocking fact is that those being held criminally accountable aren’t even the ones spouting the misinformation. It wasn’t the marketing people or sales reps but those at the very top. And the government doesn’t even have to prove they knew of it or were engaged in it!

Now look, I understand and support the theory of corporate and top down negligence when an employee does something wrong. You don’t and you shouldn’t need to prove a conspiracy or even knowledge at the top for such. Just that managment should’ve known or enabled the actions of their subordinates through lax control or vague directions or poor hiring practices or whatever. There probably was that here. But do we really want to take that from a civil or bureaucratic matter to a criminal one?!

Yes, it is a misdemeanor the three execs plead to. No, it has no jail time or even probation involved; merely fines. But still.

While I’m sure this isn’t the first example of the bizarre criminalization of basic business activity, I for one am a little scared by this.